FDA says in a final rule that some antibacterial soaps can no longer be marketed
"We have no scientific evidence that they are any better than plain soap," official says
The Food and Drug Administration has issued a final rule that throws cold water on claims that antibacterial soaps and washes are more effective than regular soap.
The new rule bans antibacterial soaps and body washes containing certain ingredients from being marketed, because the ingredients were not proved to be safe and effective for long-term daily use, the FDA said Friday.
The rule applies to antibacterial soaps and washes that contain one or more of 19 active ingredients, including the most commonly used chemicals triclosan and triclocarban, but it does not affect consumer hand sanitizers or antibacterial wipes.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a written announcement.
“In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” she added.
Companies will have one year to either remove the ingredients or no longer market their products before the final rule is effective (PDF).
The American Cleaning Institute released a statement in response in which it indicated that the FDA had data showing the safety and effectiveness of antibacterial soaps. Manufacturers plan to provide additional science and research to fill any data gaps, according to the statement.
“In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium chloride and chloroxylenol. … Consumers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, daycare centers and other commercial settings,” said the statement by the American Cleaning Institute, a trade organization that represents the producers of cleaning products.
The FDA issued a proposed rule in 2013 that required the manufacturers of antibacterial hand soaps and body washes to prove that their products were more effective than plain soap and were safe for long-term use.
However, “antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness,” according to the FDA’s new final rule. The FDA even noted that some manufacturers have started to remove certain active ingredients from their products.
What does the science say about antibacterial soaps? A 2007 paper published in the journal Clinical Infectious Diseases found that using triclosan-containing consumer soaps seemed to not offer an additional health benefit over using regular soap and water.
Rather, regularly using such antibacterial consumer soaps may be linked to the growth of dangerous drug-resistant bacteria, according to the paper.
“Those who are out washing with it in the community think they’re doing a good health measure when, in fact, they aren’t,” said Dr. Stuart Levy, professor of molecular biology and microbiology at Tufts University School of Medicine and a co-author of the paper.
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So, the new FDA rule “seems like a prudent step to prevent a possible, albeit theoretical, future adverse impact, and since the public still has the option of using hand sanitizers, which work faster and better than the current consumer ‘antibacterial’ soaps, I can be supportive of the ruling,” said Elaine Larson, associate dean for research at Columbia University School of Nursing and a co-author of the paper.
For the paper, researchers reviewed 27 studies on the potential hazards versus benefits of antibacterial soaps. The researchers concluded, “Further studies of this issue are encouraged.”
“This whole issue of antibiotics, where they do good and they don’t do good, has not been explained well enough to the public, but I think it can be now,” said Levy, who conducted some of the earliest studies on antibiotic resistance. “We sort of led the cause to eliminate the use of triclosan in washes, because quite honestly, it didn’t show any improvement.”